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Benefits:

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Competitive salary

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Opportunity for advancement

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Training & development

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Job Summary

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We are seeking a skilled System Validation Engineer to join our team! As a System Validation Engineer, you will be responsible for validating documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) and responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.

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Responsibilities

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Validate GMP Lab systems and Equipment

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Identify and escalate, as necessary project risks and issues to the CSVC Manager

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Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs

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Be able to prepare reports on defects and problems that arise during system testing

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Have solid oral and written communication skills and teamwork skills

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Work with business representatives to ensure the test cases reflect business rules and processes

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Fulfills the role of a subject matter expert role for critical quality and compliance GxP end-use applications supporting Animal Health business processes

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Work with business representatives to ensure the test cases reflect business rules and processes

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Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

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Qualifications

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Be a good team player, able to meet deadlines and handle changing priorities

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Have strong judgment capabilities to clarify requirements when necessary

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Have the ability to work with cross functional teams

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Have solid experience working with validated systems

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GMP/Regulated lab, more than 5 years of CSV experience required

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Technical writing Experience

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Highly skilled in Computerized System testing and validation in the healthcare industry

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Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)

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Solid project organizational skills and ability to multi-task with strong analytical problem-solving skills

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Excellent communication including written, verbal, and listening skills

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Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision

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BS in Science or Technical Writing Degree